1. Field of the Invention
The present invention relates generally to mechanisms and methods for dilating nasal passages and delivering medication, drugs, or other compounds. More particularly, the present invention concerns an improved internal nasal dilator for increasing nasal breathing efficiency and for delivering a time-released compound within the nostrils of a user, and a method of making the same.
2. Discussion of the Prior Art
It is well documented that collapsed or constricted nasal passageways result in a multitude of bodily problems, including sleep apnea, sinus infection, and other respiratory ailments. Another well-known problem associated with reduced passageways is snoring. In this condition, audible sounds produced by the vibration of the soft palate and internal nasal structure can be a nuisance to persons within hearing distance and can affect the quality of sleep of the snoring person.
To alleviate these ailments and conditions, a variety of nasal dilator mechanisms, including external and internal versions, have been developed over time. Prior art external nasal dilators often take the form of an adhesive strip that is worn on an exterior portion of the nose and function to lift the walls of the nasal passages. Unfortunately, the frictional grab-strength required by these external dilators often causes discomfort or damage to the skin and soft facial tissues of the user. Furthermore, external placement of these dilators exposes them to a variety of forces arising from rubbing against objects, such as pillows, that can prematurely dislodge the dilator.
Prior art internal nasal dilators, on the other hand, function within the nostrils of the user, and as a result are not subject to being prematurely dislodged by external forces. These dilators are typically held in place by a clamping mechanism that pinches the septum generally along two contact points, or by stretching the nostrils enough to result in a compressive force on the dilator sufficient to hold it in place. The non-adjustability of these dilators, however, are problematic given that there are an infinite number of sizes and shapes of human nostrils. The pinching mechanisms of these dilators are also problematic in that they cause discomfort to the user, including pain where prolonged usage is necessary. The fact that some of these internal dilators must stretch the nostrils to a greater extent than is necessary to simply dilate the nostril also causes further discomfort and noticeability.
The prior art also includes nasal dilators combined with gaseous delivery systems for providing a measured flow of medicine to the user. These combinations, however, typically require that an external source be securely connected to the dilator during usage, which makes them problematically cumbersome. Connection to an external source also reduces comfort by limiting the user to certain positions in order to ensure proper operation, which may further inhibit the user from sleeping. Furthermore, these combinations include notoriously complex mechanical, electrical, or pneumatic components that make their manufacture time-consuming and expensive.
U.S. Pat. No. 6,561,188 to Ellis (Ellis '188), for example, discloses an internal dilator having an internal medicine source. In that arrangement, an anti-histamine layer (27) is not attached to an external source, see FIGS. 8A–8E. The layer (27) is attached to other permeable filter layers and overlays the outlet of the nostrils when in place. However, locating the antihistamine near the outlet of the nostrils reduces the effectiveness of delivery and may be wholly inappropriate for other types of medicines, drugs, or compounds because the proximity to ambient air outside the nose results in a measurable percentage of undelivered medicine. Locating the source up-stream from the mucosal lining within the nasal passageway further diminishes the effectiveness of the combination by preventing the administration of medicine during exhalation. Furthermore, the structure of the disclosed mechanism is so large (relative to the volume of the nasal passages) and complex that it may inhibit air flow during normal breathing and may be prohibitively costly to manufacture.
Due to these and other problems and limitations in the prior art, an improved nasal dilator and delivery mechanism is needed.